Baricitinib
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From MedlinePlus, U.S. National Library of Medicine
Specialty pharmacy: therapy management checklist, storage and cold chain, dosing calendar, Medicare Part D coverage.
Boxed warning
WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE), and THROMBOSIS WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE), and THROMBOSIS See full prescribing information for complete boxed warning. Increased risk of serious bacterial, fungal, viral and opportunistic infections leading to hospitalization or death, including tuberculosis (TB). Interrupt treatment with OLUMIANT if serious infection occurs until the infection is controlled. OLUMIANT should not be given to patients with active tuberculosis. Test for latent TB before and during therapy, except for COVID-19; treat latent TB prior to use.
Monitor all patients for active TB during treatment, even patients with initial negative, latent TB test. ( 5.1 ) Higher rate of all-cause mortality, including sudden cardiovascular death with another Janus kinase inhibitor (JAK) vs. TNF blockers in rheumatoid arthritis (RA) patients. ( 5.2 ) Malignancies have occurred in patients treated with OLUMIANT. Higher rate of lymphomas and lung cancers with another JAK inhibitor vs. TNF blockers in RA patients. ( 5.3 ) Higher rate of MACE (defined as cardiovascular death, myocardial infarction, and stroke) with another JAK inhibitor vs. TNF blockers in RA patients. ( 5.4 ) Thrombosis has occurred in patients treated with OLUMIANT.
Increased incidence of pulmonary embolism, venous and arterial thrombosis with another JAK inhibitor vs. TNF blockers. ( 5.5 ) SERIOUS INFECTIONS Patients treated with OLUMIANT are at risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.1 )] . Most patients with rheumatoid arthritis who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt OLUMIANT until the infection is controlled. Reported infections include: Active tuberculosis, which may present with pulmonary or extrapulmonary disease.
OLUMIANT should not be given to patients with active tuberculosis. Patients, except those with COVID-19, should be tested for latent tuberculosis before initiating OLUMIANT and during therapy. If positive, start treatment for latent infection prior to OLUMIANT use. Invasive fungal infections, including candidiasis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease. Bacterial, viral, and other infections due to opportunistic pathogens. The risks and benefits of…
Janus Kinase Inhibitor
Dosing in kidney impairment
Dosage Modifications for Patients with Renal Impairment or Hepatic Impairment Rheumatoid Arthritis Renal Impairment Dosage modifications for patients with rheumatoid arthritis and renal impairment are described in Table 3 . [See table below.] Hepatic Impairment OLUMIANT is not recommended for use in patients with severe hepatic impairment.
Interrupt OLUMIANT, if increases in ALT or AST are observed and drug-induced liver injury (DILI) is suspected, until the diagnosis of DILI is excluded [see Warnings and Precautions]. COVID-19 Renal Impairment Dosage modifications for patients with COVID-19 and renal impairment are described in Table 4 . [See table below.] Hepatic Impairment It is not known if dosage adjustment is needed in patients with COVID-19 and severe hepatic impairment.
OLUMIANT should only be used in patients with COVID-19 and severe hepatic impairment if the potential benefit outweighs the potential risk. Interrupt OLUMIANT, if increases in ALT or AST are observed and DILI is suspected, until the diagnosis of DILI is excluded [see Warnings and Precautions] . Alopecia Areata Renal Impairment Dosage modifications for patients with alopecia areata and renal impairment are described in Table 5 . [See table below.] Hepatic Impairment OLUMIANT is not recommended for use in patients with severe hepatic impairment.
Interrupt OLUMIANT, if increases in ALT or AST are observed and DILI is suspected, until the diagnosis of DILI is excluded [see Warnings and Precautions].
| Renal Impairment Stage | Estimated Glomerular Filtration Rate (eGFR) | Recommendation |
| Mild | 60 – <90 mL/minute/1.73 m2 | 2 mg once daily |
| Moderate | 30 - <60 mL/min/1.73 m2 | 1 mg once daily |
| Severe | <30 mL/minute/1.73 m2 | Not recommended |
| Renal Impairment Stage | Estimated Glomerular Filtration Rate (eGFR) | Recommendation |
| Mild | 60 - <90 mL/min/1.73m2 | 4 mg once daily |
| Moderate | 30 - <60 mL/min/1.73m2 | 2 mg once daily |
| Severe | 15 - <30 mL/min/1.73m2 | 1 mg once daily |
| End Stage Renal Disease, Patients on Dialysis, or Acute Kidney Injury | <15 mL/min/1.73m2 | Not recommended |
| Renal Impairment Stage | Estimated Glomerular Filtration Rate (eGFR) | Recommendation | |
| If the recommended dosage is 2 mg once daily | If the recommended dosage is 4 mg once daily | ||
| Mild | 60 – <90 mL/minute/1.73 m2 | Maintain dosage | |
| Moderate | 30 – <60 mL/min/1.73 m2 | Reduce to 1 mg once daily | Reduce to 2 mg once daily |
| Severe | <30 mL/minute/1.73 m2 | Not recommended | |
Dosing in liver impairment
Hepatic Impairment No dose adjustment is necessary in patients with mild or moderate hepatic impairment. The use of OLUMIANT has not been studied in patients with rheumatoid arthritis or alopecia areata and severe hepatic impairment and is therefore not recommended. OLUMIANT has not been studied in patients with COVID-19 and severe hepatic impairment.
OLUMIANT should only be used in patients with COVID-19 and severe hepatic impairment if the potential benefit outweighs the potential risk [see Dosage and Administration and Clinical Pharmacology] .
Preparation and administration
Alternative Administration for Patients Unable to Swallow Tablets For patients who are unable to swallow whole tablets, an alternative mode of administration may be considered: Oral dispersion Gastrostomy tube (G tube) Nasogastric tube (NG tube) or orogastric tube (OG tube) Intact tablets are not hazardous. Tablets may be crushed to facilitate dispersion.
It is not known if powder from the crushed tablets may constitute a reproductive hazard to the preparer. If tablets are crushed, use proper control measures (e.g., ventilated enclosure) or personal protective equipment (i.e., N95 respirator). Dispersed tablets are stable in water for up to 4 hours. Preparation Instructions for Alternative Administration : Oral administration of dispersed tablets in water: For patients who are unable to swallow whole tablets, 1-mg, 2-mg, or 4-mg baricitinib tablet(s), or any combination of tablets necessary to achieve the desired dose up to 4-mg may be placed in a container with approximately 10 mL (5 mL minimum) of room temperature water, dispersed by gently swirling the tablet(s) and immediately taken orally.
The container should be rinsed with an additional 10 mL (5 mL minimum) of room temperature water and the entire contents swallowed by the patient ( Table 7 ). Administration via G tube: For patients with a G tube, 1-mg, 2-mg, or 4-mg baricitinib tablet(s), or any combination of tablets necessary to achieve the desired dose up to 4-mg may be placed in a container with approximately 15 mL (10 mL minimum) of room temperature water and dispersed with gentle swirling.
Ensure the tablet(s) are sufficiently dispersed to allow free passage through the tip of the syringe. Withdraw entire contents from the container into an appropriate syringe and immediately administer through the gastric feeding tube. Rinse container with approximately 15 mL (10 mL minimum) of room temperature water, withdraw the contents into the syringe, and administer through the tube ( Table 7 ).
Administration via NG or OG tube: For patients with a NG or OG tube, 1-mg, 2-mg, or 4-mg baricitinib tablet(s), or a combination of tablets necessary to achieve the desired dose up to 4-mg may be placed into a container with approximately 30 mL of room temperature water and dispersed with gentle swirling. Ensure the tablet(s) are sufficiently dispersed to allow free passage through the tip of the syringe.
Withdraw the entire contents from the container into an appropriate syringe and immediately administer through the enteral feeding tube. To avoid clogging of small diameter tubes (smaller than 12 Fr), the syringe can be held horizontally and shaken during administration. Rinse container with a sufficient amount (minimum of 15 mL) of room temperature water, withdraw the contents into the syringe, and administer through the tube ( Table 7 ). [See table below.] 15 mL NG tube or OG tube 30 mL 15 mL
| Administration via | Dispersion Volume | Container Rinse Volume |
| Oral dispersion | 10 mL | 10 mL |
| G tube | 15 mL | 15 mL |
| NG tube or OG tube | 30 mL | 15 mL |
Drug interactions
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- Baricitinib
Label text (3 paragraphs)
In patients taking strong Organic Anion Transporter 3 (OAT3) inhibitors (e.g., probenecid) the recommended dosage should be reduced. ( 2.7 , 7.1 )
7.1 Strong OAT3 Inhibitors Baricitinib exposure is increased when OLUMIANT is co-administered with strong OAT3 inhibitors (such as probenecid), hence the dosage of baricitinib should be reduced by half the recommended dose [see Dosage and Administration ( 2.2 , 2.3 ) and Clinical Pharmacology ( 12.3 )] .
7.2 Other JAK Inhibitors or Biologic DMARDs OLUMIANT has not been studied in combination with other JAK inhibitors or with biologic DMARDs [see Indications and Usage ( 1.1 , 1.2 )] .
Contraindications
None. None.
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
E*Likelihood score E*: Unlikely to be a cause of idiosyncratic clinically apparent liver injury but has the potential to cause reactivation of hepatitis B.
Baricitinib is an orally available small molecule inhibitor of Janus kinases that is used to treat moderate-to-severe rheumatoid arthritis, severe alopecia areata, and, in combination with remdesivir, severe COVID-19 in hospitalized patients requiring supplementary oxygen. Baricitinib is associated with transient and usually mild elevations in serum aminotransferase levels during therapy but has yet to be linked to cases of clinically apparent acute liver injury.
ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary Based on the findings from animal reproduction studies, OLUMIANT may cause fetal harm during pregnancy. Available data from clinical trials and postmarketing case reports with OLUMIANT exposure in pregnancy are insufficient to inform a drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. There are no human data on chronic baricitinib exposure throughout pregnancy. There are risks to the mother and the fetus associated with rheumatoid arthritis in pregnancy (see Clinical Considerations) . Consider the risks and benefits with chronic use of OLUMIANT during pregnancy.
In animal embryo-fetal development studies, oral baricitinib administration to pregnant rats and rabbits at exposures equal to and greater than approximately 11 and 46 times the maximum recommended human dose (MRHD) of 4 mg/day, respectively, resulted in reduced fetal body weights, increased embryolethality (rabbits only), and dose-related increases in skeletal malformations. No developmental toxicity was observed in pregnant rats and rabbits treated with oral baricitinib during organogenesis at approximately 2 and 7 times the exposure at the MRHD, respectively.
In a pre- and post-natal development study in pregnant female rats, oral baricitinib administration at exposures approximately 24 times the MRHD resulted in reduction in pup viability (increased incidence of stillborn pups and early neonatal deaths), decreased fetal birth weight, reduced fetal body weight gain, decreased cytotoxic T cells on post-natal day (PND) 35 with evidence of recovery by PND 65, and developmental delays that might be attributable to decreased body weight gain. No developmental toxicity was observed at an exposure approximately 5 times the exposure at the MRHD (see Data) .
The background risks of major birth defects and miscarriage for the indicated population(s) are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Report pregnancies to Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979). Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Published data suggest that increased disease activity is associated with the risk of developing adverse pregnancy outcomes in women with rheumatoid arthritis.
Adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth…
Breastfeeding (LactMed)
No information is available on the use of baricitinib during breastfeeding. Expert opinion recommends that mothers not breastfeed while taking baricitinib. An alternate drug is preferred, especially while nursing a newborn or preterm infant. The manufacturer recommends that women avoid nursing during therapy and for 4 days after the last dose.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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